Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021629
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
APIDRA | INSULIN GLULISINE RECOMBINANT | 1000 UNITS/10ML (100 UNITS/ML) | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | None | No | No |
APIDRA | INSULIN GLULISINE RECOMBINANT | 300 UNITS/3ML (100 UNITS/ML) | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Discontinued | None | No | No |
APIDRA SOLOSTAR | INSULIN GLULISINE RECOMBINANT | 300 UNITS/3ML | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | No |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/30/2022 | SUPPL-42 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021629s042lbl.pdf | |
11/30/2022 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021629s042lbl.pdf | |
11/15/2019 | SUPPL-39 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021629s039s040lbl.pdf | |
11/15/2019 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021629s039s040lbl.pdf | |
12/20/2018 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021629s037s038lbl.pdf | |
12/20/2018 | SUPPL-37 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021629s037s038lbl.pdf | |
12/20/2018 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021629s037s038lbl.pdf | |
12/20/2018 | SUPPL-37 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021629s037s038lbl.pdf | |
02/25/2015 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021629s030lbl.pdf | |
05/14/2014 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021629s029lbl.pdf | |
09/06/2013 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021629s028lbl.pdf | |
02/24/2009 | SUPPL-8 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021629s008lbl.pdf | |
02/24/2009 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021629s008lbl.pdf | |
10/24/2008 | SUPPL-15 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021629s015lbl.pdf | |
04/12/2007 | SUPPL-10 | Efficacy-New Route Of Administration | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021629s010lbl.pdf | |
12/20/2005 | SUPPL-2 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021629s001,002lbl.pdf | |
12/20/2005 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021629s001,002lbl.pdf | |
04/16/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021629lbl.pdf |